Data / Medical devices / Canada / Abk Biomedical
Abk Biomedical: FDA-registered device maker in Halifax Nova Scotia, Canada, 1 510(k) clearance
Abk Biomedical is registered with the FDA (registration 3013505221) in Halifax Nova Scotia, Canada. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 13, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013505221
- Address
- 155 Chain Lake Drive Unit 32, Halifax Nova Scotia, Canada, B3S 1B3
- Owner or operator
- ABK Biomedical (10086030)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- March 7, 2024
- Registered through
- 2026
- Brand names listed
- Easi-Vue® embolic microspheres System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Vascular, For Promoting Embolization | KRD | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 13, 2024 | K234123 | Easi-Vue® embolic microspheres System | KRD | Substantially Equivalent | Abk Biomedical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated February 13, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.